Investigational Device Exemptions; Intraocular Lenses

The Food and Drug Administration (FDA) is issuing a final rule to remove the regulations on investigational device exemptions (IDE's) for intraocular lenses (IOL's). An IOL is an implant intended to surgically replace the natural lens of the human eye. FDA believes it is no longer necessary to maintain particularized regulations on IOL investigations because approved IOL's are now widely available and investigations of IOL's can be conducted under the investigational device regulations applicable to medical devices generally. This action is intended to eliminate confusion within the clinical research community and to provide uniformity to investigational device studies.